Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from March to April 96
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Schriever
- body weight: 2.9 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 18 days
- Identification: tattoo numbers in the ear

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- rel. Humidity (%): 52 - 58
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 mL (corresponded to 64-73 mg substance)
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
13 days
Number of animals or in vitro replicates:
1 male- since severe intolerance reactions occurred in this animal, the other animals originally foreseen for this study were not exposed to the substance for humane reasons.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
4

Applicant's summary and conclusion

Executive summary:

In a local tolerance test on the rabbit eye according to OECD TG 405 in the initial test using one animal a single application of the test substance into the conjunctival sac provoked severe irritation which only gradually subsided in the course of 13 days. The other animals oroginally foreseen for this study wer not exposed to the substance for animal welfare reasons.